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Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
Sponsor: Zealand Pharma
Summary
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Official title: A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-12-11
Completion Date
2028-12-31
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Glepaglutide 10 mg
Administered twice weekly by subcutaneous injection for a maximum of 24 months
Locations (16)
Mayo Clinic - PPDS
Rochester, Minnesota, United States
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska, United States
Cleveland Clinic-9500 Euclid Ave
Cleveland, Ohio, United States
Vanderbilt University Medical Center-Tennesse-1211 21st Ave S
Nashville, Tennessee, United States
UZ Leuven - PPDS
Leuven, Belgium
LHSC - University Hospital
London, Ontario, Canada
AP-HP - Hôpital Beaujon
Clichy, Hauts-de-Seine, France
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Skawina, Lesser Poland Voivodeship, Poland
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP
Warsaw, Masovian Voivodeship, Poland
Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi
Lodz, Poland
St Mark's Hospital (Central Middlesex Hospital)
Ealing, United Kingdom